MTAP 2: WEEK 9

Paracelsus AKA. Theophrastus Bombastus Von Hohenheim (Father of Toxicology)

"All things are poison and nothing is without poison, only the dose makes that a thing is not a poison" This quote is said by?

1. Methamphetamine 2. Tetrahydrocannabinol (THC)

Lab procedure for specimen handling: What are the most common metabolites tested in urine samples?

Oral Absorption

Pharmacokinetics: Accounts for the most of the extravascular doses administered

1. Phase 1 reactions (hydroxylation by cytochrome p450 enzyme) 2. Phase 2 reactions (glucuronidation or sulfation)

Pharmacokinetics: Liver modification of drugs may be?

1. Binding of a drug to circulating blood components 2. Binding to fixed receptors 3. Passage of the drug through membrane barriers 4. Ability to dissolve in structural or storage lipids

Pharmacokinetics: What are the factors determining the distribution pattern of a drug?

Detectable and corrected

Quality Assurance Programs: A lab must document that any carryover that might occur between aliquots/extracts in the confirmatory batch is?

1. The linear range 2. Limit of detection 3. Limit of quantitation

Quality Assurance Programs: These must be documented and periodically re-evaluated for each confirmatory drug test

The DOH national reference lab (For External Quality Assurance Program)

Quality Assurance Programs: Who is asked to conduct a proficiency testing for screening and confirmatory drug testing labs?

Memorandum for Records (MFR)

Recording: Refers to a record to document specimen that has been rejected or canceled Includes recent and corrective measures done

1. Availability of confirmatory lab 2. Distance of confirmatory lab from screening lab

Analytical Methods: The release of the results will be dependent on?

1. Accomplish custody and control form (CCF) 2. Initial lab report 3. Letter request for confirmatory test

Analytical Methods: The screening lab must submit all samples with positive results to any DOH accredited confirmatory drug testing lab Together with the sample, the following documents will be submitted

20 SQUARE METERS It shall only designate an area for drug testing within the clinical lab

Facilities and Equipment: A DOH accredited hospital or non-hospital based secondary or tertiary categorical clinical lab which intends to put up his screening laboratory for drug testing need not provide an additional __ to its existing floor area

60 SQUARE METERS in floor area 30 SQUARE METERS in work area with exhaust fan, sink, fume hood, and stock room, and instrumentation room

Facilities and Equipment: A confirmatory lab shall have?

5 prospective clients at a time must have a hand washing facility, toilet facility, and stall for the orderly collection of specimen

Facilities and Equipment: A lab of whatever category shall have, within its premises, an area which can receive or accommodate at least?

20 SQUARE METERS in floor area 10 SQUARE METERS in work area with an exhaust fan, sink and storage cabinet

Facilities and Equipment: A screening lab shall have?

1. All equipment must be calibrated and maintained according to the procedures in the manufacturer's manual 2. There shall be a record indicating that equipment has been calibrated and or checked on a regular schedule based on established procedures 3. Trained personnel should be assigned to calibrate equipment regularly 4. Corrective actions and recommendations must likewise be documented when instruments fail to function as expected

Facilities and Equipment: Additional information about calibration and maintenance

1. The collection device shall not affect or alter the specimen collected 2. All specimen containers shall be properly labelled and sealed 3. If collection device is unique and integral part of the collection and analytical testing procedure it must be registered by an appropriate agency designated by DOH as a medical device 4. Single use items are not unique collection devices and are not required to be cleared by the DOH

Facilities and Equipment: Additional information regarding collection device

There shall be adequate lighting and ventilation in all work areas (in order to interpret and encode results properly)

Facilities and Equipment: Details about Lighting and Ventilation in the laboratory

10 mL capacity plain test tube

Facilities and Equipment: What is the collection devices for blood specimens?

Self-sealing transparent plastic bag 200 mg capacity

Facilities and Equipment: What is the collection devices for scalp hair specimens?

Patch placed on skin and transferred in a container with suitable transport medium

Facilities and Equipment: What is the collection devices for sweat specimens?

Specimen is frozen immediately and transported in clean, dry, tightly capped plastic container with no additives

Facilities and Equipment: What is the collection devices for tissue specimens?

Screw capped, wide mouth 30-60 mL capacity Polyethylene container

Facilities and Equipment: What is the collection devices for urine specimens?

1. Name of instruments, model, serial number 2. Name of accessory parts 3. Name and address of local distributor 4. Date and amount of purchase 5. Date of calibration 6. Date of malfunction 7. Date of repair/corrective action(s) taken 8. Recommendations 9. Name of authorized person who performed the calibration/maintenance of equipment

Facilities and Equipment: What should be the contents of calibration/maintenance record?

1. CYP 1 (Specific to Estrogen, 3 subfam) 2. CYP 2 (13 subfam) 3. CYP 3 (Specific to Testosterone, 1 subfam)

Families of Cytochrome p450: Drug and Steroid metabolism

1. Specific requirements in the method for cleaning of glassware must be followed 2. If no specifications are listed, then glassware should be washed in a warm detergent solution and thoroughly rinsed with tap water and then with distilled/deionized water

Good Lab Practice: General provisions for glassware

Must be free from interference for the analyte being measured

Good Lab Practice: General provisions for reagent water

Drug testing lab owner > Head of lab > Technical Personnel and Administrative Personnel

Hierarchy of the lab

1. Clerk 2. Secretary

Lab Personnel: Administrative personnel include?

1. Physically unable to go to the lab or designated collection site 2. Involved in crime scene 3. Involved in post-accident 4. Critically ill

Lab procedure for specimen handling: Conditions where unobserved specimen collection is allowed

1. Failure of the authorized specimen collector to sign the CCF 2. Failure to check and record specimen temperature with appropriate remarks

Lab procedure for specimen handling: Criteria for specimen rejection that are correctable

1. Incompatibility of the ID number on the specimen received by the lab with number on the CCF 2. Absence of ID number on the specimen 3. No printed authorized specimen collector name and signature on the CCF 4. Broken or tampered seal on the specimen container 5. Insufficient quantity of specimen

Lab procedure for specimen handling: Criteria for specimen rejection that are non-correctable

Volume: 30-45 mL Temperature: 32.5 to 37.7°C Physical Characteristics: Varies from almost colorless, straw or light yellow to dark yellow, yellow-orange, or amber

Lab procedure for specimen handling: Ideal temperature, volume, and characteristics of normal untampered urine

Unobserved Specimen Collection Unobserved samples are subject to specimen validity tests

Lab procedure for specimen handling: Refers to a procedure where samples are collected in the absence of the authorized specimen collector or submitted samples that are not collected at collection site or laboratory.

Step 5

Lab procedure for specimen handling: The client/donor/subject must affix his/her signature at __ of the CCF during collection of urine for drug testing

Results of Analysis Must contain: 1. Test results (and of control/calibrator/standard) 2. lab identification of specimen tested 3. Identification of individual performing and reviewing test results 4. Evidence of review by the certifying analyst and confirmatory tests 5. Evidence of confirmatory worksheets or other review documents of comparison of the initial and confirmatory testing data to ensure consistent results 6. Strike out changes made on test results and other records must be properly annotated by the responsible individual

Recording: This contains records for all screening/confirmatory test result and/or of documents

1. A DOH-accredited laboratory shall STORE AND ARCHIVE all record electronically to duly authorized application service provider 2. The lab shall VALIDATE that the method used to create electronic records provides an accurate representation of the original records 3. The method used to create electronic records must PREVENT the alteration of any storage information and/or data 4. The method used must allow EASY retrieval and reproduction of the original records 5. Lab shall assure the INTEGRITY of data electronically stored under its information technology facilities without prejudice to pertinent statutes on privacy/confidentiality and transparency 6. Lab shall assure integrity of data by TRANSMITTING it electronically from their facility to DOH within the prescribed time and measures to counter disruption of transmitted data are installed 7. The lab shall assure that the data stored electronically have BACKUP copies for the purpose of audit by the DOH at as a measure to preclude inadvertent of records 8. Electronic transmittal of drug testing results shall be COURSED by the DOH authorized application service provider

Recording: What are the procedures for maintaining an electronic storage system?

1. The lab must retain all records generated to support test results for at least 2 years. 2. All records associated with positive results or particular specimen under legal challenge shall be maintained indefinitely

Recording: What are the procedures for storage of lab records?

IDTOMIS (Integrated Drug Test Operations Management Information System)

Recording: What is an example of a authorized application service provider?

Must be stored for a minimum of 2 years in lab or as required by law

Recording: What is the procedure for the storage of collection site records?

Good laboratory practice

Refers to a quality system of management controls for research labs and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests From physio-chemical properties through acute to chronic toxicity tests

Therapeutic Drug Monitoring (TDM)

Refers to a traditional term use for the activity of measuring drug concentrations to tailor the dose of the medication to an individual

Pharmacology

Refers to the study of drugs, their properties, interactions, therapeutic effects, and potential side effects on living organisms

Pharmacodynamics Intensity and duration of the observed pharmacologic effect are proportional to the concentration of the drug at the receptor

Refers to the study of the biochemical and physiological effects of drugs on the body. It involves the interactions between drugs and their targets, and the resulting effects on the body's normal functions.

1. Total number of specimen received and examined as classified according to mandatory, random, and other reasons 2. The number of specimen that were reported as positive for each drug (listed separately), adulterated, substituted, rejected for testing, invalid result 3. The number of specimens sent for confirmatory testing ( for screening laboratory)

Reporting: A lab must submit annually to the BHFSA report containing?

1. All specimen submitted shall have a corresponding lab result issued within 15 days 2. A positive screening result shall be subjected to confirmatory analysis. The final report shall be based on the confirmatory results 3. The screening lab shall be the only authorized lab to release the final report 4. All lab reports of a screening laboratory shall bear the signature of the analyst and head of lab. For a confirmatory lab, the report shall bear the signatures of the analyst chief chemist and head of lab 5. All confirmatory drug test results should specify the concentration of the limit of detection of the method of the drug or metabolites. However for clinical or therapeutic purposes, the concentration shall be quantified 6. A lab shall report all test results using the DOH standard electronic lab report form. The electronic report must be transmitted in a manner that ensures the confidentiality and security of the information 7. Reports for an adulterated or substituted test result must be based on an initial and confirmatory validity test 8. The lab must report the specific validity test results for a specimen that is reported adulterated or substituted 9. No result can be relayed through telephone

Reporting: Guidelines for reporting a laboratory result

1. Allow the client/donor/subject to explain any circumstances leading to the test result 2. Evaluate alternative medical explanations for the positive, adulterated, substituted, or invalid test results 3. Review current medical explanations for the positive, adulterated, substituted, or invalid test result

Reporting: Prior to making a final decision in the specimen that was reported positive, adulterated, substituted, or an invalid test result by the lab, the head of the lab shall?

10 working days

Reporting: The report must be submitted to the BHFS by mail, fax, or email within __ after the end of the year

1. Send the specimen to another DOH accredited lab capable of identifying the interfering substance/adulterant 2. report the result as test cancelled if the explanation provided by the client/donor/subject is acceptable (immediate direct observed collection not required) or unacceptable (immediate direct observed collection required)

Reporting: When the lab reports an invalid result due to the possible presence of an unidentified interfering substance/adulterant, the head of lab shall?

Separate serum then immediately freeze specimen

Specimens: Proper handling and storage of blood

To be determined

Specimens: Proper handling and storage of fingernails

Deep frozen at least -8 to -10 degrees Celsius

Specimens: Proper handling and storage of saliva

Store at cool and dry place

Specimens: Proper handling and storage of scalp hair

To be determined

Specimens: Proper handling and storage of sweat

Macerated and frozen

Specimens: Proper handling and storage of tissue

long storage at -20 degree Celsius

Specimens: Proper handling and storage of urine

1. Minimize the number of personnel handling the specimen 2. document the date and the purpose on the CCF each time a specimen is handled or transferred 3. Identify each person who handle the specimen 4. When a courier service is utilized, the time of receipt from the collection site and the time of delivery to the lab must be documented on the CCF 5. Place specimen in sealed plastic bags and an appropriate transport container designed to minimize damage and seal top securely to eliminate the possibilities of tampering 6. Ensure that the CCF accompanies the appropriate specimen transport container

Specimens: The following must be observed in the transport of specimen

1. 2-6 degrees Celsius 2. 1 day

Specimens: Urine may be stored initially in the refrigerator between __ for not more than __

2-3 days

Specimens: Urine samples for drug testing is only viable for

Keratin (Drug for ~6 months, Ethanol ~3months) The more keratinized, the longer the retention time

Specimens: Which brought in fingernails and scalp hair can capture metabolites from drugs?

True

True/False: All rejected specimen should be reported to the head of laboratory stating the reasons for rejection

1. Adulterated, substituted, and diluted 2. Improperly collected, handled, and stored 3. Improperly documented

Urine Specimen Validity Test: A urine specimen is invalid when?

An accredited drug testing facility with at least secondary clinical lab capability

Urine Specimen Validity Test: Perform confirmatory validity tests using other procedures, instruments, and/or methods on the same sample All unobserved samples for validity testing shall be submitted to?

Validity Test

Urine Specimen Validity Test: Refers to a method to determine the integrity of the specimen

1. Glass 2. Metals 3. Plastics 4. Computer 5. Cartridges 6. Others

Waste Disposal: Examples of non-biodegradable waste

Chemical Waste Non-chemical hazardous waste can be disposed directly into the sink or treated as ordinary domestic waste

Waste Disposal: Refers to a type of waste that must undergo pretreatment prior to disposal

Biohazard Waste

Waste Disposal: Refers to either a liquid, solid, or concentration of solid waste which because of its quantity, concentration, physical, chemical, or infectious characteristics, may pose a substantial or potential threat to human health or to the environment when improperly, treated, stored, transported, or disposed

20 square meters in floor area

A screening lab shall have at least?

Combined chromatographic separation and mass spectrophotometric identification in the same procedure (e.g. GC-MS, LC-MS, or LC-MS-MS)

Analytical Methods: A lab that performs a confirmatory analysis using validated analytical procedure by NRL of an aliquot of specimen submitted from a screening lab in order to identify and quantify the presence of metabolite The procedure must?

Screening Lab (may conduct repeat screening test on same sample prior to confirmatory test) They may use: 1. Registered testing kits approved by the DOH 2. Instrumented screening method

Analytical Methods: A lab that performs a validated test to differentiate negative specimen from a specimen that requires further testing for drugs and/or metabolite

Confirmatory 1. Liquid Chromatography tandem Mass Spectrophotometry (LC-MS) 2. Gas Chromatography tandem Mass Spectrophotometry (GC-MS)

Analytical Methods: Hyphenated technique using combination of two sophisticated technologies or other such as modern and acceptable techniques

Notify requesting party to refer to another confirmatory lab

Analytical Methods: In case the test cannot be done, what is the procedure?

Chromatography (Screening test) 1. Thin layer chromatography (TLC) 2. Gas Chromatography (GC) 3. Liquid Chromatography (e.g. High Performance LC)

Analytical Methods: Separation of a mixture is the main outcome of this method In this process, a mixture of substances is separated in a stationary medium

1. 3-5 working days 2. 24 hours after submission

Analytical Methods: The confirmatory lab must release within __ upon receipt of the specimen depending on the workload and availability of equipment and supplies For criminal case-related drug testing, the confirmatory result should be released __ after submission of specimen

1. 5 days 2. 5 days

Analytical Methods: The screening lab must keep specimen with a negative result for a minimum of __ upon receipt of result In case the result is not retrieved by the client/donor/subject, the lab has the option to discard the specimen after __

Immunoassays (Screening tests) 1. Enzyme Immunoassay (EIA) 2. Enzyme-multiplied Immunoassay Technique (EMIT) 3. Fluorescence polarization 4. Radio Immunoassay (RIA)

Analytical Methods: These methods are used for preliminary screening/initial screening based on an antibody-antigen reaction where small amounts of the drug and/or metabolites may be detected

1. A suitable clean surface for handling the specimen and completing the required paperwork 2. A secured temporary storage capability to maintain a specimen until it is tested or shipped to the lab 3. An area to provide clients/donor/subject privacy appropriate to the specimen being collected (e.g. toilet) 4. A controlled and secured area for supplies and records 5. A poster or information bulletin with a detailed description of the proper specimen collection processes 6. A source of water for hand washing external to toilet facility (for urine collection)

Collection Site: A collection site must have the following

1. 10 working days 2. Kept confidential

Collection Site: The DTL must secure a permit from HFSRB/CHD __ prior to the scheduled activity except in Crime scenes/Post-accidents The secured permit must be __ among drug testing laboratories, requesting party, and HFSRB/CHD

1. Random testing 2. Follow up testing 3. Reasonable suspicion/cause 4. Crime scene and post-accident 5. If the client is critically ill or disabled

Collection Site: What are the allowable conditions for a remote site specimen collection

Self-sealing transparent plastic bag, 200 mg capacity

Facilities and Equipment: What is the collection devices for fingernail specimens?

Screw capped wide mouth 30 mL capacity Polyethylene container

Facilities and Equipment: What is the collection devices for oral fluid/saliva specimens?

1. Eating, drinking, and smoking should not be permitted in any area where activities might adversely influence product quality or where staff may be exposed to potentially harmful agents 2. There should be areas designated for eating, drinking, and rest

Good Lab Practice: For Drinking and Smoking

1. Where pest control is needed as in the case of storage of papers and records, it should be carried out in such a way as to ensure that the chemical used to do so do not contaminate other materials

Good Lab Practice: For pest control

1. Laboratories should maintain current quality assurance program 2. All lab activities including sampling, testing, methods, instrument operation, data generation, and corrective action should be described in the program

Good Lab Practice: For quality assurance

1. Must meet the specifications in the method 2. If not specified then Analytical Reagent Grade (AR) or American Chemical Society grade chemicals (ACS) are better to be used for analysis

Good Lab Practice: General provisions for chemicals and reagents

1. Has general and overall supervision of the facility and all aspects of lab work 2. Has general supervision and conduct of all lab personnel 3. Formulates and implements standard operation manual 4. Prepares financial and annual reports of the lab 5. Provides other administrative support services such as communications, security, and maintenance services

Lab Personnel: ADMINISTRATIVE duties and responsibilities of head of lab?

1. Verifies the completeness of Custody and Control Form (CCF) 2. Prepares specimen for analysis 3. Examines, processes, and analyzes specimen for drug testing 4. Interprets, records, releases, and signs out lab results 5. Assists in the implementation of quality assurance program 6. Assists in the evaluation of reagents, supplies, and equipment 7. Refers to the Head of Lab as the need arises

Lab Personnel: Duties and responsibilities of an Analyst

Hospital Director

Lab Personnel: If the drug testing laboratory is hospital based, who is the owner of the drug testing lab?

Must either be... 1. Registered Chemist 2. Registered Chemical Engineer 3. Registered Medical Technologist 4. Registered Pharmacist

Lab Personnel: Qualifications of an Analyst

1. At least a high school graduate, who underwent APPROPRIATE TRAINING (anyone can be a collector as long as there is appropriate training)

Lab Personnel: Qualifications of an Authorized Specimen Collector

1. Theory and practice of the drug testing procedures (all procedures, since he/she will be the one to validate and release results) 2. Chain of custody, reporting, and record keeping (must have proper documentation of every step) 3. Review and interpretation of test results 4. Quality assurance program (maintain quality at all times) 5. Dangerous drugs regulations and policies

Lab Personnel: Required trainings the head of lab must have?

1. Analytical methods and procedures 2. Maintenance of chain of custody 3. Reviewing and reporting test results 4. Proper remedial action in response to problems that may arise 5. Quality control procedures and practices 6. Dangerous drugs regulations and policies

Lab Personnel: Required trainings to possess by an Analyst

1. Collection and procedure for each type of specimen 2. Chain of Custody and Record Keeping 3. Specimen integrity and security 4. Dangerous Drugs regulations and policies

Lab Personnel: Required trainings to possess by an Authorized Specimen Collector

1. The collection procedure changes significantly (e.g. a new CCF is used) 2. The Authorized Specimen Collector made a mistake that caused the test to be cancelled

Lab Personnel: Retraining of Authorized Specimen Collector shall be required under the following conditions

1. Supervises and directs all analytical procedures of the lab 2. Assures quality of all lab test results 3. Issues, signs out and interprets lab results 4. Evaluates and recommends reagents, supplies, and equipment 5. Reviews the CCF and reports received from authorized collector 6. Interviews the client/donor/subject if necessary 7. Reviews pertinent medical records of client/donor/subject if necessary 8. Cancels the results of all specimens which are not collected or testing not in accordance with the DTL manual 9. Reviews, rejects, and refers for confirmation and retesting all specimen and test results that are positive, adulterated, substituted or invalid 10. implements remedial actions necessary to maintain satisfactory operation and performance in the laboratory 11. Directs protocol for preventive maintenance of equipment 12. Provides comprehensive, continuing training and education of personnel related to conduct of DTL

Lab Personnel: TECHNICAL duties and responsibilities of head of lab?

1. Analysts 2. Authorized specimen collector 3. Laboratory aide

Lab Personnel: Technical personnel include?

1. Restricts unauthorized personnel to enter the collection site during collection 2. Verifies identity of the client/donor/subject 3. Provides security to specimen supplies, records, and documents at collection site 4. Informs the client/donor/subject the procedures of specimen collection 5. Performs only one specimen collection at the time 6. Accepts and seals the specimen container in the presence of the client/donor/subject 7. Accomplishes the CCF

Lab Personnel: The Authorized Specimen Collector must observe the following to ensure the security of specimen at the collection site

1. Employers of the client/donor/subject 2. Investigator at the crime scene 3. Complainant 4. Owner/Administrator of establishment

Lab Personnel: The following are persons who are not authorized to collect specimen

1. A licensed physician certified in Clinical Pathology by the Philippine Board of Pathology 2. Licensed physician trained in lab management and drug testing operations (Must have appropriate training)

Lab Personnel: To be qualified to run a drug testing lab, the Lab head must be?

1. Toilet water COLORING agents should be placed in toilet tanks or in the toilet bowl. Any other sources of water in the enclosure where urination occurs will be secured prior to collection (deters dilution of specimen) 2. Authorized Specimen Collector will ask client/donor/subject to REMOVE any unnecessary outer garments such as coat/jackets that might conceal items or substances that could be used to tamper with or adulterate the client/donor/subject's urine specimen. The Authorized Specimen Collector will ensure that all personal belongings such as purse or briefcase remain with the outer garments 3. The client/donor/subject will be instructed to WASH and dry his/her hands prior urination, afterwards they will remain in the presence of the authorized specimen collector and will not have access to any unregulated source of water, soap dispenser, cleaning agent, or any other materials that could be used to adulterate the specimen 4. The authorized specimen collector will give or the client/donor/subject will CHOOSE a clean specimen container from available supplies. The client/donor/subject may provide his/her specimen in the privacy of a toilet or otherwise partitioned area that allows for individual privacy. The client/donor/subject we will be instructed not to flush the toilet until the specimen is handed the authorized specimen collector 5. Upon receiving the specimen from the client/donor/subject, the authorized specimen collector will CHECK the volume of urine in this specimen container, check the temperature of the urine specimen, inspect the specimen to determine its color and appearance for any signs of contaminants. Any unusual findings will be noted on the CCF

Lab procedure for specimen handling: The following precautions shall be taken to ensure the integrity of the specimen

At least 5-mL whole blood is extracted from client donor subject placed in a 10 mL capacity test tube without anticoagulant at a designated area

Lab procedure for specimen handling: Visual privacy requirements when collecting a specimen for BLOOD

The neat saliva/tissue/fingernails specimen is collected directly into an appropriate container by the client/donor/subject under the direct observation of the authorized specimen collector at a designated area

Lab procedure for specimen handling: Visual privacy requirements when collecting a specimen for SALIVA/TISSUE/FINGERNAIL

The authorized specimen collector shall collect available scalp hair 1 cm above the scalp from the client/donor/subject at a designated area

Lab procedure for specimen handling: Visual privacy requirements when collecting a specimen for SCALP HAIR

The sweat patch is applied to the client/donor/subject's upper arm, chest, or back and removed by the authorized specimen collector at a designated area

Lab procedure for specimen handling: Visual privacy requirements when collecting a specimen for SWEAT

A lab must have the required restroom/stall with a toilet for the client/donor/subject to have privacy while collecting the urine sample

Lab procedure for specimen handling: Visual privacy requirements when collecting a specimen for URINE

1. All errors must be DOCUMENTED, recorded in a Memorandum for Record (MFR) and duly signed by the authorized specimen collector 2. If the authorized specimen collector signature cannot be corrected by a Memorandum for Record, the lab must report the specimen REJECTED for testing and provide a reason on the report

Lab procedure for specimen handling: What are the appropriate remedial measures for correctable errors?

1. The client/donor/subject REMOVES all unnecessary outer garments (such as coat or jackets) after which he/she will be subjected to a bodily search 2. The authorized specimen collector DIRECTS the client/donor/subject to empty his/her pockets and checks items that may be used to adulterate specimen 3. The client/donor/subject WASHES and dry hands prior to collection then they must remain in the presence of the authorized specimen collector and must not have access to anything that could be used to affect the specimen 4. The authorized specimen collector either gives or allows the client/donor/subject to SELECT the collection container from available supplies. The specimen container is opened in full view of the client/donor/subject 5. The authorized specimen collector directs the client/donor/subject go in the toilet facility for URINATION and to provide at least 60-mL either collected in single or split specimen 6. The authorized specimen collector shall OBSERVE closely the entire collection procedure and take note of the conduct and demeanor of client/donor/subject for attempts of substitution, alteration, dilution of specimen 7. A tampered specimen is sent the laboratory for validity testing and the authorized specimen collector shall DOCUMENT the tampering on the CCF with appropriate remarks. The authorized specimen collector shall instruct the client/donor/subject to provide another urine specimen immediately under direct observed collection This second specimens shall also be sent for examination exactly 8. After the client/donor/subject HANDS the specimen, the authorized specimen collector must measure the temperature, check volume, and inspect its physical characteristics 9. The authorized specimen collector and client/donor/subject must keep the specimen in FULL VIEW at all times prior to sealing of all specimen containers (a tamper-evident label/seal must be used to secure the entire specimen container) 10. Both authorized specimen collector and client/donor/subject must have FIXED their signature on the seal together with the date and time of collection 11. The authorized specimen collector may ask the client/donor/subject LIST any prescription medication he/she may have taken for the past two weeks at the back of the CCF (analyst copy). Authorized specimen collector shall distribute each copy as required 12. In case of specimen collection at a REMOTE SITE and transport via a courier/mail, the specimen container together with the CCF shall be placed in a seal labeled and secure transparent plastic bag

Lab procedure for specimen handling: What are the basic steps in collecting urine specimen for drug testing

1. A lab must retain a specimen that was reported as negative for a minimum of 5 days after receipt of result 2. A lab must retain a specimen that was reported either as positive, adulterated, substituted, or invalid results for a minimum of 15 days upon receipt of results. A specimen may be retained for a maximum of 1 year upon request, if no such request is received a specimen may be discarded 3. A retained specimen must be kept in a second location appropriately to ensure its availability for any necessary retesting during an administrative or judicial proceeding

Lab procedure for specimen handling: What are the conditions for retention of specimen?

1. Failure to print and print the accessioner's name 2. Failure to print and sign the analyst's name 3. The Analyst accidentally initials the CCF rather than providing a signature for non-negative results (Analyst initials are acceptable for negative results) 4. The accessioner fails to mark one of the "primary specimen bottle seal intact" boxes, but the lab reported a "rejected for testing" result with an appropriate comments on the "Remarks" line

Lab procedure for specimen handling: What are the conditions that will not cause specimen rejection or cancelation of tests WITHIN the lab?

1. Discrepancies of the lab name and address 2. Incomplete/Incorrect/Unreadable employer name or address 3. Name of the head of the lab is not indicated 4. Incomplete/Incorrect address of the Head of the lab 5. Incorrect entry of the client/donor/subject's ID number 6. Unmarked "Reason for test" box 7. Unmark "Drug tests to be performed" box 8. The collection site address is not indicated 9. Unmarked specimen collection box 10. Unmarked observed box (if applicable) 11. The date and time of collection is not indicated 12. Incorrect entry of name of delivery courier service 13. The client/donor/subject's name inadvertently appears on the lab copy of the CCF or on the tamper-evident labels used to seal the specimen bottles (must only be a reference number)

Lab procedure for specimen handling: What are the conditions that will not cause specimen rejection or cancelation of tests at the RECEIVING area?

1. Client/donor/subject's signature is missing on the lab copy of the CCF and the authorized specimen collector failed to provide a comment that the client/donor/subject refused to sign the form 2. Analyst failed to sign the CCF for a specimen being reported drug positive, adulterated, substituted, rejected for testing, or invalid test result 3. Electronic report provided by the lab does not contain all the data elements required for the DOH standard electronic lab report for a specimen being reported drug positive, substituted, rejected for testing, or invalid test result

Lab procedure for specimen handling: What are the conditions/errors that may require the head of lab to cancel a test?

1. Head of lab must contact the authorized specimen collector to obtain a statement to verify that the client donor subject refused to sign the lab copy, if authorized specimen collector cannot provide such a statement, head of lab must cancel the test 2. Head of lab must have a statement from the analyst that he or she inadvertently forgot to sign the CCF but did, in fact, properly conduct the certification review 3. Head of the lab must require the lab to modify and retransmit a corrected electronic report

Lab procedure for specimen handling: What are the corrective measures that the head of lab must do prior to cancelation of the test?

The authorized specimen collector shall 1. Prepare and secure all collection supplies, materials, and record 2. Verify client/donor/subject's identification 3. Explain the basic collection procedure to the client/donor/subject 4. Answer any reasonable appropriate questions the client/donor/subject may ask regarding the collection procedure

Lab procedure for specimen handling: What are the preliminary procedures for specimen collection?

Samples are collected while observed/in the presence of the Authorized Specimen Collector

Lab procedure for specimen handling: What is the principle of observed specimen collection?

Inform the client/donor/subject that the specimen is not being tested under the guidelines, and the procedures are not subject to review by the NRL

Lab procedure for specimen handling: When a lab performs a procedure it has specimen for which it is not accreted, it must?

1. The lab must provide a unique accession number upon the entry of specimen to the lab 2. Inspect specimen submitted and the CCF to verify integrity and identity of specimen 3. Examine packaging for evidence of tampering during transit 4. Compare the information on the sample bottles within the package 5. Document all discrepancies

Lab security and Chain of Custody: Steps taken by the lab during accessioning

Drug Testing Custody and Control Form (CCF) must be approved by the Bureau of Health Facilities Services (BHFS/HFSRB)

Lab security and Chain of Custody: This must be used to document a collection of a specimen by all drug testing labs It is used to document Chain of Custody from the time client/donor/subject gives the specimen to the authorized specimen collector until the specimen is received for testing, and the CCF used for each type of specimen collected should be available at the drug testing labs

1. Control of access of unauthorized individuals and ensure no unauthorized individual can gain access to specimens, aliquots, or records 2. All authorized visitors must be escorted at all times 3. A lab must maintain a record that documents the dates, times of entry and exit, and purpose of entry of authorized escorted visitors accessing secured areas

Lab security and Chain of Custody: What are the security measures employed by the lab

1. Develop comprehensive procedural and scientific standards for all aspects of drug testing program 2. Promote quality assurance program of all drug testing labs 3. Assist DOH designated agencies in the conduct of accreditation of confirmatory labs for drug testing and in the evaluation of test kits and reagents 4. Resolve the conflicting/challenge results among confirmatory labs 5. Train technical staff of drug testing labs 6. Conduct research and development of drug testing and other related activities

Mandates of the NRL

Agonists

Pharmacodynamics: Refers to a compound that can bind to and cause activation of a receptor If it binds to the receptor then an effect will be formed

Competitive Inhibitor

Pharmacodynamics: Refers to a compound that can bind to the receptor of whatever compound that will bind to that particular receptor By blocking the receptor, it prevents the activation of the receptor, thereby downregulating the receptor activity

Allosteric Inhibitor

Pharmacodynamics: Refers to a compound that which inhibits the action of the agonist at the binding site of the receptor, resulting in a low response

Allosteric enzyme

Pharmacodynamics: Refers to an enzyme that contains a region to which small regulatory molecules called effectors may bind in addition to and separate from the substrate binding site and thereby affect the catalytic activity

Liver (metabolism takes place in the microsomal fraction of hepatocytes) Converts lipophilic nonpolar molecules to more polar water soluble forms

Pharmacokinetics: Principal organ responsible for xenobiotic metabolism

Bioavailability

Pharmacokinetics: Refers to the fraction of a drug that is absorbed into the systemic circulation

First Pass Effect This is relevant when comes to oral dosing and something that needs to be considered in choosing types of drugs to be applied Only orally applied drugs are affected by first pass effect.

Pharmacokinetics: Refers to the phenomenon where the liver may extensively metabolize a drug with a high hepatic extraction rate before it reaches the systemic circulation leading to low oral bioavailability

Renal Excretion Alteration in renal function may have a profound effect on clearance and apparent half-life of the parent compound or its active metabolites

Pharmacokinetics: The major pathway for the elimination of most water-soluble drugs or metabolites and is important in TDM

Fatty Acids

Pharmacokinetics: These can displace a drug from its protein binding sites if the drug is weakly bound

1. Passive diffusion through aqueous channels in the cellular junctions and tight junctions (space between cells) 2. Through lipid cell membranes 3. Carriers into or out of cells (for drugs with appropriate characteristics) 4. Engulfment of the cell membrane and then released inside the cell or expelled via membrane limited vesicles out of the cell (for very impermeant drugs)

Pharmacokinetics: What are the mechanisms of drug permeation?

East Avenue Medical Center (EAMC) By virtue of Department Order No. 393 E s. 200

Philippine Drug Laws: The designated NRL for Environmental and Occupational Health, Toxicology, and Micronutrient assay by virtue of department order No.393 E s. 200 In coordination with BHFS/HFSRB (regulating arm of the Department of Health), shall assure the competence, integrity, and stability of drug testing centers nationwide

RA 9165 (Comprehensive Dangerous Drugs Act of 2002)

Philippine Drug Laws: The government shall pursue an intensive and unrelenting campaign against the trafficking and use of dangerous drugs and other similar substances through an integrated system of planning, implementation, and enforcement of anti-drug abuse policies, programs and projects This is the declaration of?

1. The lab is required once a year of maintenance PT sample 2. Correctly identify and confirm 90% of the total drug challenges over two consecutive PT cycles 3. Correctly quantify 80% of the total drug challenges within +5% of the appropriate reference or peer group mean as measured over two consecutive PT cycles 4. Have no more than two quantitative result differ more than 20% from the target value over 2 consecutive PT cycles 5. Correctly identify and quantify at least 80% of the total drug challenges

Quality Assurance Programs: An accredited lab must satisfy the following criteria on the maintenance PT samples to maintain its certification

1. At least one control registered and validated by the DOH to contain NO drug metabolite 2. At least one control that has the concentration of the drug or metabolite at 25% ABOVE the heart of concentration 3. At least one control that has concentration of the drug or metabolite at 25% BELOW the cut off concentration

Quality Assurance Programs: For batch quality control requirements when conducting a screening drug test for kits, each batch for specimen must contain the following types of quality control samples

1. No false positive results 2. Correctly identify and confirm at least 80% of the total drug challenges on each of the 3 sets of samples 3. Quantitative values for at least 80% of the total drug challenges must be within +/-5% of the calculated reference group mean 4. No quantitative value on a drug concentration may differ by more than 20% from the calculated reference group mean 5. For a individual drug, correctly detect and quantify at least 50% of the total drug challenges

Quality Assurance Programs: For initial proficiency testing requirements for confirmatory lab, the lab must satisfy the following criteria on three consecutive sets of initial PT samples within three months

1. The linear range of the analysis 2. Limit of detection (LOD) 3. Limit of quantitation (LOQ) 4. Accuracy and precision at the cut off concentration 5. Accuracy and precision at 40% of the cut off concentration 6. Potential for interfering substances

Quality Assurance Programs: In the internal quality assurance program of confirmatory labs for a validation of a confirmatory drug test, the lab must demonstrate a document?

1. The ability to differentiate positive and negative samples 2. The performance of the test around the cut off concentration 3. The performance of the test results at several concentrations between 0-150% of the cut of concentration Performance characteristics of new lots of testing kits must be evaluated prior to its use

Quality Assurance Programs: In the internal quality assurance program of screening labs for a validation of a screening drug test, the lab must demonstrate?

1. A 3-point calibrator at the cutoff 2. At least one negative control 3. at least one positive control within 25% above the cut off concentration 4. At least one blind control in every batch 5. At least 10% of each batch must be calibrators at controls

Quality Assurance Programs: In the internal quality assurance requirements when conducting a confirmatory drug test, each batch of specimen must contain at a minimum the following types of QC samples

1. At least 50% above the cut off concentration for either the initial test or the confirmatory test depending on which is to be evaluated 2. At least 40% above the cut off concentration When the PT sample is designated as a retest sample 3. Concentration is at another concentration for special purposes 4. For each PT cycle, the set of PT samples for each lab will vary but within each calendar year each lab will analyze the same total set of samples 5. The lab must do, to the greatest extent possible, handle, test, and report a PT sample in a manner identical to that used for a client/donor/subject specimen unless otherwise specified

Quality Assurance Programs: In the qualitative and quantitative specifications of a proficiency test sample for confirmatory laboratory, the concentration of the drug and/or metabolites in a PT sample are

40% of the cutoff concentration

Quality Assurance Programs: On a retest reconfirmation challenge, the batch must have one control that has the concentration of the drug or metabolite at or below __

1. Drugs and or metabolites in the drug classes that each lab must have the capability to test for 2. No more than two drug classes to imitate real client/donor/subject specimen

Quality Assurance Programs: Quantitative and Qualitative specifications for a proficiency test sample may contain?

1. An interested lab shall submit to NRL a letter of intent for proficiency testing, properly accomplished application form and protocol prior to the schedule proficiently testing 2. Application form includes detailed related information on both administrative and analytical procedures

Quality Assurance Programs: Steps for the application of Certificate of Proficiency (COP)

1. There must be an initial validity test (first) on one aliquot and a confirmatory validity test (second) on a second aliquot. In some cases both validity tests may use the same procedure, instruments, and/or methods 2. The performance characteristics (e.g. accuracy, precision, LOD, LOQ, linearity, specificity) shall be documented for each validity test as appropriate 3. The LOD of suspected adulterants shall be determined 4. Each analytical run of specimen for which an initial or confirmatory validity test is being performed should include appropriate calibrators and controls

Quality Assurance Programs: What are the analytical and quality control requirements for performing urine specimen validity tests?

1. Each batch of specimen must contain the types of QC sample as a drug testing lab using kits 2. At least ten batch must be calibrators and controls 3. A lab must document any carryover that might occur between aliquots during the initial testing is detectable and corrected

Quality Assurance Programs: What are the internal quality assurance program for instrumented testing

Screening: 1. Shall pass the proficiency test conducted by the NRL before the renewal of their accreditation Confirmatory: 1. As part of accreditation, a lab shall pass the initial proficiency test and maintenance proficiency testing conducted by NRL

Quality Assurance Programs: What are the requirements for accreditation of screening and confirmatory lab

1. Each drug testing lab is required to have both negative and non negative blind samples submitted with its client/donor/subject specimen 2. During the initial 90-day period of any new drug testing lab, it must ensure that at least 3% of the total number of client/donor/subject specimen submitted are blind samples 3. After initial 90 day. the drug testing lab must ensure that a minimum of 1% the total number of client/donor/subject specimen are blind samples 4. Approximately 80% of the blind samples may be negative and the remaining are non-negative 5. Each drug positive samples must be spiked only with those drugs for which the drug testing lab is testing for its specimen 6. A blind sample is submitted to the lab together with a drug testing laboratory's client/donor/subject 7. A blind sample is always submitted using the same HFSRB approved CCF as used for a client/donor/subject specimen. The authorized specimen collector provides the required information to ensure that the CCF has been properly completed as well as providing fictitious initials on the specimen label/seal (ASC must also indicate that sample is blind sample on the head of lab copy where client/donor/subject would normally provide signature) 8. Each drug testing lab must ensure that the required blind samples are distributed throughout the total number of client/donor/subject specimen rather than submitted as a single group of samples

Quality Assurance Programs: What are the requirements to submit blind samples?

1. Must be validated as to its contact by the supplier using initial and confirmatory tests 2. Supplier must provide information regarding shelf life of blind sample 3. If blind sample is positive, concentration of drug it contains must be between 1.5 and 2x the initial drug test cutoff concentration 4. If blind sample is adulterated or substituted, its characteristics must clearly show that it is an adulterated or substituted sample when validated by the supplier

Quality Assurance Programs: What is the internal quality assurance program for BLIND SAMPLES submitted by a drug testing laboratory?

The head of lab must 1. Contact the blind sample supplier and determine if the supplier may have made a mistake by preparing the blind sample 2. Contact the authorized specimen collector and determine if he/she made an error when preparing the blind sample for the lab 3. If there is no obvious reason for inconsistent result, head of lab will notify both the drug testing lab for which the blind sample was submitted and the NRL 4. NRL will investigate blind sample error and send a report to the head of lab and the drug testing lab describing the investigation and corrective action taken

Quality Assurance Programs: What must be done when an inconsistent result is reported on a blind sample

Quality Assurance Program Record

Recording: Must include internal quality control and external

Inventory of reagent, supplies, and materials

Recording: Refers to a record of all reagents, supplies, and materials used

Chain of Custody

Recording: Refers to a record that must reflect the actual chain of custody procedures (e.g. the movement between individuals or movement to/from temporary storage) that are used for handling specimen

Equipment, Maintenance, and Repair record

Recording: Refers to a record that should document that all instruments are properly maintained, calibrated, cleaned, and monitored including directive measures and recommendations done

1. Chain of custody 2. Memorandum for records 3. Results of analysis 4. Inventory of reagent, supplies, and materials 5. Equipment, maintenance, and repair record 6. Storage of collection site records 7. Quality Assurance Program Record 8. Storage of lab records 9. Electronic storage system

Recording: The lab shall develop and maintain clear and well documented records detailing procedures for collection, accessioning, result of analysis, and remedial measures which shall not be limited to

1. Blood (min of 5 mL) 2. Fingernails (To be determined) 3. Scalp Hair (100 mg hair or its equivalent in number of strands or 1 cm above the scalp) 4. Tissue (To be determined) 5. Saliva/Oral Fluid (1.5 mL is the primary specimen, 0.5 mL for challenge test) 6. Sweat (1 patch worn for 7-14 days) 7. Urine (60 mL in single container or 30 mL each in two separate containers for split specimen)

Specimens: What are the minimum quantity of specimen to be collected

1. Blood (For reasonable suspicion/cause) 2. Fingernails (For reasonable suspicion/cause) 3. Saliva/Oral fluid (For reasonable suspicion/cause, pre-employment, random) 4. Scalp hair (For reasonable suspicion/cause, pre-employment, random) 5. Sweat (patch) (For follow-up, return to duty) 6. Tissue (For reasonable suspicion/cause) 7. Urine (For reasonable suspicion/cause, pre-employment, random)

Specimens: What are the types of specimens a drug testing laboratory may collect?

Applied Pharmacokinetics

The discipline that uses the principles of form walking a text to enhance safety and effectiveness of a drug in an individual patient This is an aspect of pharmacology that will most strongly influence the interpretation of TDM results

1. Dose of Drug given is known 2. Accurate timing of sample collection 3. Variation in collection and sample handling can affect quality of concentration data 4. Stability of drug after collection 5. Physiologic changes in the patient

Therapeutic Drug Monitoring: Pre-analytical factors that affect Therapeutic Drug Monitoring Results

Falsely increased

Therapeutic Drug Monitoring: Premature sampling may lead to __ concentrations that could alter decision making given the generally narrow therapeutic range for this drug

1. Determine optimal dose of drugs that will help a patient with a limited associated harm 2. Use therapeutic drug monitoring in order to assess signs and symptoms of toxicity which will determine treatment success or failure 3. Efficacy and toxicity of some drugs can be much more difficult to monitor on clinical signs and symptoms alone and direct biomarker testing associated with therapy can be instituted to monitor efficacy and/or toxicity

Therapeutic Drug Monitoring: What are the challenges of TDM

Serum in Plain Red Top Tubes Prolonged contact of specimen to SST - drugs in the specimen will diffuse into the gel (false decrease if underfilled)

Therapeutic Drug Monitoring: What is the ideal sample for therapeutic drug monitoring

Pharmacokinetics Includes LADME 1. Liberation 2. Absorption 3. Distribution 4. Biotransformation 5. Excretion

This describes the process of uptake of drugs by the body, the distribution of the drugs into the tissue, the biotransformation they undergo, and the elimination of the drugs and their metabolites from the body

True

True/False: A drug may be tightly or loosely bound; a weekly bound drug can be displaced from its protein sites by a drug with a greater affinity for plasma protein-binding sites Protein binding of a drug also depends on the physical characteristics of the plasma proteins and on the present or absence of fatty acids or other drugs in the blood

True

True/False: All confirmatory lab must accept specimen tested positive from a screening lab with accompanying request for confirmatory testing and previous result of analysis Confirmatory lab must keep the remaining specimen tested positive, only the results of the confirmatory test will be given to the screening lab

True

True/False: Anything that alters the concentration of free drug in the plasma ultimately alters the amount of drug available to enter the tissues and interact with specific receptor systems Disease states can alter free drug concentrations, alteration of protein concentration in response to acute stress can also alter free drug concentration

True

True/False: Collection of specimen for all mandatory drug testing shall be done at a permanent facility except for crime scene and post accident No examinations must be conducted at a temporary collection facility (only remote collection)

True

True/False: For verification the client/donor/subject may obtain other documents during a reviewing of a positive, adulterated, substituted, or invalid test result The client/donor/subject must submit a written request address to the head of the drug testing lab to obtain a certified true copy of COC and pertinent analytical data

True

True/False: The mechanism of action of a drug is the biochemical or physical process that occurs at the side of action Drug action is usually mediated through a receptor, cellular enzymes as well as structural or transport proteins are important examples of drug receptors

True

True/False: The relationship between Serum drug concentration and clinical outcome forms the basis for TDM. One of the most interpretative errors encountered regarding TDM is the presumption that a concentration within a reported therapeutic range will ensure treatment success in the absence of toxicity and concentrations outside this range will not. The probability of success and toxicity are a continuum across the concentration range, differences in metabolism, physiology, and/or the underlying disease process can have an influence

True

True/False: An equilibrium exists between three and protein-bound drugs It is generally believed that only the free fraction of the drug is available for distribution and elimination and only the free drug is available to cross cellular membranes or interact with drug receptors to elicit a biological response

True

True/False: Specimen must be properly labelled, sealed and placed in a cooler with dry ice or a suitable alternative during transport

True

True/False: The absorption process depends on the drugs disassociating from its dosing form, dissolving in gastrointestinal fluids and then diffusing across biological membrane barriers into the bloodstream The rate and extent of drug absorption may vary considerably depending on the nature of the drug itself, on the matrix in which it is present, and on the physiological environment

True

True/False: The consideration of the patient's history with particular emphasis on his or her pathophysiological state and adjunct physical therapy, is essential at the initiation of drug therapy and TDM because these important factors may affect absorption, distribution, metabolism, and excretion of a drug

True

True/False: The lab shall maintain specimen test results supported by data and are reported in accordance with the following guideline rules Procedure must be in placed to ensure confidentiality of records

True

True/False: The transport of samples shall be accomplished while maintaining adequate specimen validity if a commercial carrier or postal service is used If a staff member delivers the specimen, the lab must record and report any apparent tampering with the container or specimen, and any discrepancy in the specimen and the CCF

1. Nitrite concentration is confirmed to be greater than or equal to 500 ug/dl 2. pH is less than 3 or greater than or equal to 11 3. The specimen contains an exogenous substance (a substance not considered a normal component of urine) 4. The specimen contains an endogenous substance at a concentration greater than what is considered normal physiological concentration

Urine Specimen Validity Test: Criteria for a urine specimen determined as adulterated

A urine specimen is reported diluted if the initial or confirmatory tests have creatinine and specific gravity results of 1. Creatinine concentration <1768 umol/L 2. Specific Gravity is <1.003 3. Creatinine and Specific Gravity do not meet the criteria for a substituted or invalid result

Urine Specimen Validity Test: Criteria for a urine specimen determined as diluted

A urine specimen is reported substituted for non-human urine specimen when both the initial and confirmatory specific gravity tests have the following results 1. Creatinine concentration <442.0 umol/L 2. Specific Gravity is <1.002 or greater than or equal to 1.020

Urine Specimen Validity Test: Criteria for a urine specimen determined as substituted

1. Temperature check 2. Normal physical appearance (e.g. Color, odor, excessive foaming) 3. Reactions or responses characteristic of an adulterant obtained during initial or confirmatory drug tests (e.g. non recovery of standards, unusual response) 4. Possible unidentified interfering substance or adulterant 5. Urine specific gravity, pH, and nitrites 6. Urine creatinine concentration 7. Validity tests for presence of oxidizing adulterants as needed

Urine Specimen Validity Test: Initial validity tests on urine include the following procedures

1. Use of sanitary LANFILL 2. COMPOSTING of biodegradable waste materials 3. RECYCLING scheme for factory returnable, feed, fermentable, fertilizer, fine crafts, and filling materials 4. non-hazardous waste can be disposed of with domestic/municipal/city waste where a municipal procedure COLLECTION system is available

Waste Disposal: What is the various methods of disposal for biodegradable waste?

1. Dose 2. Dosing Interval 3. Administration Route 4. Drug Properties

What are the drug specific characteristics of Pharmacokinetics?

1. Standardize procedure of drug testing services 2. Implement quality assurance in drug testing labs nationwide

What are the objectives of EAMC regarding drug testing?

1. LADME 2. Age 3. Weight 4. Sex 5. Lifestyle 6. Smoking 7. Illness 8. Medications

What are the patient specific characteristics of Pharmacokinetics?

This covers all accredited government and private drug testing labs in the Philippines

What is the scope of the NRL?